Marker Therapeutics Announces First Patient Treated in Off-the-Shelf Program
Marker Therapeutics (Nasdaq: MRKR) — Oct 6, 2025 announced the first patient was treated in the Phase 1 RAPID study testing MT-401, a multi-antigen recognizing (MAR) T cell off-the-shelf (OTS) product.
The first participant received the initial dose of 100x10^6 cells and was monitored for 28 days; the therapy was reported as well tolerated with no treatment-related adverse events. The OTS program initially targets AML and MDS and may expand to other indications. Marker said commercially sourced leukapheresis from healthy donors could enable treatment as fast as 72 hours. The program is supported by non-dilutive funding from the FDA, NIH SBIR, and CPRIT.
Marker Therapeutics (Nasdaq: MRKR) — 6 ottobre 2025 ha annunciato che il primo paziente è stato trattato nello studio di fase 1 RAPID che testa MT-401, un prodotto di cellule T in grado di riconoscere molteplici antigene (MAR) off-the-shelf (OTS).
Il primo partecipante ha ricevuto la dose iniziale di 100x10^6 cellule ed è stato monitorato per 28 giorni; la terapia è risultata ben tollerata con assenza di eventi avversi correlati al trattamento. Il programma OTS mira inizialmente AML e MDS e potrebbe espandersi ad altre indicazioni. Marker ha dichiarato che una leucafereza commercialmente fornita da donatori sani potrebbe permettere un trattamento in massimo 72 ore. Il programma è supportato da finanziamenti non diluitivi provenienti da FDA, NIH SBIR e CPRIT.
Marker Therapeutics (Nasdaq: MRKR) — 6 de octubre de 2025 anunció que el primer paciente fue tratado en el estudio de fase 1 RAPID que evalúa MT-401, un producto de células T de reconocimiento de múltiples antígenos (MAR) ready-to-use (OTS).
El primer participante recibió la dosis inicial de 100x10^6 células y fue monitoreado durante 28 días; la terapia se informó como bien tolerada sin eventos adversos relacionados con el tratamiento. El programa OTS tiene como objetivo inicial AML y MDS y podría ampliarse a otras indicaciones. Marker señaló que la leucaféresis obtenida comercialmente de donantes sanos podría permitir el tratamiento en tan solo 72 horas. El programa cuenta con financiamiento no dilutivo de la FDA, el NIH SBIR y el CPRIT.
Marker Therapeutics (나스닥: MRKR) — 2025년 10월 6일은 멀티-항원 인식(MAR) T 세포의 오프-더-쉘프(OTS) 제품인 MT-401를 시험하는 1상 RAPID 연구에서 첫 번째 환자가 치료를 받았다고 발표했습니다.
첫 참여자는 초회 투여량으로 100x10^6 세포를 받았고 28일간 모니터링되었습니다; 이 치료는 치료 관련 부작용이 보고되지 않음으로 보고되었습니다. OTS 프로그램은 초기에는 AML과 MDS를 대상으로 하며 다른 적응증으로 확장될 수 있습니다. Marker는 건강 기증자로부터의 상업적으로 조달된 백혈병 분리( leukapheresis )가 치료를 72시간 이내에 가능하게 할 수 있다고 말했습니다. 이 프로그램은 FDA, NIH SBIR, 및 CPRIT의 비확대자금(non-dilutive)으로 지원됩니다.
Marker Therapeutics (Nasdaq : MRKR) — 6 octobre 2025 a annoncé que le premier patient a été traité dans l’étude de Phase 1 RAPID évaluant MT-401, un produit de cellules T à reconnaissance multi-antigénique (MAR) prêt-à-l’emploi (OTS).
Le premier participant a reçu la dose initiale de 100x10^6 cellules et a été suivi pendant 28 jours ; la thérapie a été jugée bien tolérée sans événements indésirables liés au traitement. Le programme OTS vise initialement l’AML et le MDS et pourrait s’étendre à d’autres indications. Marker a déclaré que la leucaphérèse provenant de donneurs sains, commercialement obtenue, pourrait permettre un traitement en aussi peu que 72 heures. Le programme est soutenu par un financement non dilutif du FDA, du NIH SBIR et du CPRIT.
Marker Therapeutics (Nasdaq: MRKR) — 6. Oktober 2025 gab bekannt, dass der erste Patient in der Phase-1-Studie RAPID behandelt wurde, die MT-401, ein multie Antigen-erkennendes (MAR) T-Zellprodukt off-the-shelf (OTS) testet.
Der erste Teilnehmer erhielt eine Anfangsdosis von 100x10^6 Zellen und wurde über 28 Tage überwacht; die Therapie wurde als gut verträglich gemeldet mit keine behandlungsbedingten Nebenwirkungen. Das OTS-Programm zielt zunächst auf AML und MDS ab und könnte auf weitere Indikationen ausgeweitet werden. Marker sagte, kommerziell beschaffte Leukoapherese von gesunden Spendern könnte eine Behandlung so schnell wie 72 Stunden ermöglichen. Das Programm wird durch nicht-dilutive Finanzierung von der FDA, dem NIH SBIR und dem CPRIT unterstützt.
Marker Therapeutics (ناسداك: MRKR) — 6 أكتوبر 2025 أعلن أن أول مريض عولج في دراسة المرحلة 1 RAPID التي تختبر MT-401 ، منتج T خلية ذات تمييز متعدد المستضدات (MAR) جاهز للاستخدام من رف التخزين (OTS).
تلقى أول مشارك الجرعة الأولية من 100x10^6 خلية وتمت مراقبته لـ 28 يومًا؛ وكانت العلاجة كما قيل أنها مُتحملة جيدًا مع بدون أحداث سلبية مرتبطة بالعلاج. يهدف برنامج OTS مبدئيًا إلى AML و MDS وربما يتوسع إلى مؤشرات أخرى. وقالت Marker إن فِصد leukapheresis الذي يتم توريده تجاريًا من متبرعين أصحاء قد يتيح العلاج في أقرب وقت يصل إلى 72 ساعة. يدعم البرنامج تمويلاً غير مخفوض من FDA، و NIH SBIR، و CPRIT.
Marker Therapeutics (纳斯达克：MRKR) — 2025年10月6日 宣布，第一名患者在第1期 RAPID 研究中接受治疗，该研究测试 MT-401，一种多抗原识别（MAR）T细胞现货（OTS）产品。
第一位参与者接受了初始剂量 100x10^6 细胞，并被监测了 28 天；该疗法被报道为耐受良好，无治疗相关不良事件。OTS 计划最初针对 AML 和 MDS，并可能扩展到其他适应症。Marker 表示，来自健康捐献者的商业来源白血球分离术（leukapheresis）可能使治疗在最快 72 小时 内实现。该计划得到 FDA、NIH SBIR 和 CPRIT 的非稀释性资金支持。
- First patient dosed in Phase 1 RAPID
- No treatment-related adverse events at 28 days
- Initial MT-401 dose: 100x10^6 cells
- Non-dilutive funding from FDA, NIH SBIR, CPRIT
- Company claims potential 72-hour time-to-treatment
- Phase 1 study — clinical efficacy not established
- Safety data limited to a single patient and 28 days
- OTS claims rely on donor inventory matching validation
Insights
Marker announced first patient dosed in its off-the-shelf MAR‑T Phase 1 study with encouraging initial safety.
Marker Therapeutics initiated the Phase 1 RAPID trial and treated the first patient with the off‑the‑shelf MAR‑T product MT‑401 at the starting dose of 100x106 cells. The company reports the product was well tolerated with no treatment‑related adverse events during the 28‑day monitoring window, mirroring prior MAR‑T safety observations.
The business mechanism is clear: an OTS inventory built from commercially sourced leukapheresis units aims to shorten time‑to‑treatment to as fast as
Watch for additional RAPID cohort safety readouts, dose‑escalation tolerability, and any preliminary efficacy signals over the next 3–12 months; also monitor enrollment pace, HLA coverage metrics for the cellular inventory, and integration with the ongoing APOLLO program where the firm reported an objective response rate of
Marker Therapeutics initiated Phase 1 RAPID study to investigate Multi-Antigen Recognizing (MAR) T cells as an Off-the-Shelf (OTS) product to accelerate time to treatment
OTS product was well tolerated - safety data consistent with other MAR-T cell studies
HOUSTON, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that the first patient has been treated in the Company’s OTS program, with encouraging preliminary safety data.
Marker is evaluating the safety and efficacy of escalating doses of MT-401, a multi-antigen recognizing (MAR) T cell product targeting four antigens, as an OTS product in the Phase 1 RAPID study (clinicaltrials.gov Identifier: NCT06552416). The first study participant received the OTS product at the initial dose level (100x106 cells) and was monitored for 28 days. The therapy was well tolerated with no treatment-related adverse events. This observation is consistent with the favorable safety profile and tolerability previously reported for MAR-T cells. The OTS product will be initially tested in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), with the potential to be expanded to other indications.
“The initiation of our OTS program represents a major achievement,” said Juan Vera, M.D., President and CEO of Marker Therapeutics. “One of the biggest limitations to cell therapy is the time-consuming manufacturing of individualized products. With our OTS product, we are aiming to remove this bottleneck and provide a fast treatment option for patients with aggressive and rapidly progressing diseases. We believe that using commercially available leukapheresis material from healthy donors can facilitate large-scale manufacturing and expedite treatment as fast as 72 hours, while also enabling broader scalability and accessibility of cell therapies at a lower per-dose cost.”
“Having a rapid available alternative to individualized T cell production allows us to broaden our clinical investigation of MAR-T cells and to extend the OTS program to other indications,” commented Dr. Vera. “Looking ahead, we will remain focused on advancing our clinical investigation of MAR-T cells in lymphoma. We recently reported promising clinical efficacy and durability data from our APOLLO study where we have observed an objective response rate of
Marker has secured non-dilutive funding from the Food and Drug Administration (FDA), the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program and the Cancer Prevention and Research Institute of Texas (CPRIT) to support the clinical investigation of the OTS product. Using these allocated non-dilutive funds will allow the Company to proceed with the OTS program without affecting the Company’s runway and its efforts to advance its lead asset, MT-601, in the ongoing Phase 1 APOLLO study in patients with lymphoma. Marker recently reported an update from the APOLLO study (Press Release, August 26, 2025) highlighting a favorable safety profile and durable clinical responses.
To facilitate the OTS program, the Company has established a cellular inventory from commercially available leukapheresis material that was carefully selected to cover a large patient population with partially human leukocyte antigen (HLA) matched material. This approach has been validated and extensively tested in the clinic (Leen et al., Blood, 2013; Tzannou et al, Blood Adv, 2019; Tzannou et al, J Clin Oncol, 2017). Data from the ongoing RAPID trial will help inform future clinical developments of MAR-T cell products and guide their potential use as an OTS product in other indications.
“Behind this milestone is a set of scientific data and a significant body of research and development. This strategy has been tested extensively in the clinic at Baylor College of Medicine in the context of virus-specific T cells (VST). As we enroll additional patients in the Phase 1 RAPID study, we will continue to closely monitor the safety and long-term treatment effects of our OTS product. The collected data from this trial will serve as a foundation for refining and understanding the performance of MAR-T cells as an OTS product to potentially expand the OTS approach to other product candidates in our pipeline with the goal to accelerate time to treatment in other indications,” concluded Dr. Vera.
About MAR-T cells
The multi-antigen recognizing (MAR) T cell platform (formerly known as multiTAA-specific T cells) is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient's/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, MAR-T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since MAR-T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile compared to current engineered T cell approaches and may provide patients with meaningful clinical benefits.
About the Off-the-Shelf Program
MT-401-OTS is an Off-the-Shelf (OTS) multi-antigen recognizing (MAR) T cell product that targets four different tumor antigens upregulated in cancer cells (Survivin, PRAME, NY-ESO-1, WT-1). MT-401-OTS is currently investigated in the Company-sponsored Phase 1 multicenter, open-label RAPID trial (clinicaltrials.gov identifier: NCT06552416) for the treatment of patients with relapsed acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). The Company’s OTS program is supported by the National Cancer Institute of the National Institutes of Health (Award Number 1R44CA285177), the Food and Drug Administration Department of Health and Human Services (R01FD007272), and the Cancer Prevention and Research Institute of Texas (CPRIT, Award Number DP210042).
About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a Houston, TX-based clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors. The Company was founded at Baylor College of Medicine, and clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic MAR-T cell products were well tolerated and demonstrated durable clinical responses. Marker’s goal is to introduce novel T cell therapies to the market and improve patient outcomes. To achieve these objectives, the Company prioritizes the preservation of financial resources and focuses on operational excellence. Marker’s unique T cell platform is strengthened by non-dilutive funding from U.S. state and federal agencies supporting cancer research.
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Forward-Looking Statements
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; the timing, conduct, interim results announcements and outcomes of our clinical trials of our product candidates, including MT-601 for the treatment of patients with lymphoma or MT-401-OTS for the treatment of patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at WWW.SEC.GOV. The Company assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release except as may be required by law.
Media and Investor Contact
Marker Therapeutics, Inc.
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investor.relations@markertherapeutics.com
FAQ
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